Imaging Biomarkers in Clinical Trials
Current Practice & Future Trends
Traditional Criteria: RECIST, WHO, Cheson
Novel Imaging Biomarkers in Drug Development
Emerging Modalities: PET-MR, DCE-MRI, Perfusion

19 lectures with up to 11 AMA PRA Category 1 Credits

April 25 – 26, 2014
Richard B. Simches Research Center
Massachusetts General Hospital, Boston
 



COURSE OVERVIEW

Imaging biomarkers serve as important endpoints for clinical trials in the approval process for therapeutic drugs. Various criteria have been developed for objective interpretation of imaging studies. Additionally, there are emerging imaging techniques that have the potential for applications as surrogate endpoints for clinical trials.

In this program, we will review the current practice of imaging biomarkers in clinical trials in oncology. Additionally, we will highlight advanced imaging techniques that have potential as surrogate biomarkers. The educational need addresses a combination of knowledge, competence, and performance gaps. Imaging techniques and read criteria continue to evolve, and it is important for investigators to keep current with the best practices. Also, these are not used in daily clinical practice so knowledge can only be obtained from courses such as this or by reading medical literature.

We believe that didactic lectures from leading experts on topics with Q&A sessions will most efficiently disseminate the knowledge regarding imaging biomarkers and advanced imaging techniques. The lectures will include case studies of previous clinical trials, discussing their successes and failures.

LEARNING OBJECTIVES

Upon completion of this activity, participants will be able to:

  • Discuss and implement the latest imaging criteria such as RECIST and WHO
  • Identify new imaging modalities that may be used in clinical trials
  • Differentiate types of imaging modalities that can be used for different disease types

WHO SHOULD ATTEND THIS COURSE

This course is geared towards individuals from academic medical centers, pharmaceutical companies, contract research organizations, and biotechnology companies that design and manage clinical trials. These individuals include Medical Directors, Physicians, and PhD Scientists. In addition, we will target radiologists who interpret images to educate them on appropriate analysis methodology and we will target non-radiologists involved in
imaging in clinical trials.

ACCREDITATION

The Harvard Medical School is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Harvard Medical School designates this live activity for a maximum of 11 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The Royal College of Physicians and Surgeons of Canada recognizes conferences and workshops held outside of Canada that are developed by a university, academy, hospital, specialty society or college as accredited group learning activities.

AMA PRA Category 1 Credits™ claimed by physicians attending live events certified and organized in the United States for AMA PRA Category 1 Credits™ can be claimed through the agreement on mutual recognition of credits between UEMS and AMA, considered as being equal to the European Continuous Medical Education Credits (ECMEC©) granted by the UEMS. One AMA PRA Category 1 Credits™ is equivalent to one (1) hour of European EACCME Credit (ECMEC©), therefore up to 11 ECMEC© Credits are available. Each medical specialist should claim only those hours of credit that he/she actually spent in the educational activity.

PROGRAM SCHEDULE*

Friday April 25

12:00-1:00 PM

REGISTRATION

Martinos Center, CSB, and NMMI Symposia:
Molecular Imaging and Drug Development

1:00-1:30

KEYNOTE : Multimodal Functional Brain Imaging

Bruce Rosen, MD, PhD
Professor of Radiology, HMS

1:30-2:00

Pet-MRI: A unique synergistic tool for Oncologic Translations Drug Development

Alex Guimaraes, MD, PhD, Assistant Professor of Radiology, HMS

2:00-2:30

Martinos Center: Imaging Biomarkers in Neuroradiology

TBA

2:30-2:45

Questions and Panel Discussion

2:45-3:00

BREAK

3:00-3:30

Imaging for Target Discovery and Preclinical Drug Development

Matthias Nahrendorf, MD
Associate Professor of Radiology, HMS

3:30-3:50

Cancer cell Profiling by Barcoding for High Throughput and Multiplexed Protein Analyses

Cesar Castro, MD
Instructor in Medicine, HMS

3:50-4:10

Quantitative Oncologic PET-CT and PET-MR

Georges El-Fakhri, PhD
Professor of Radiology, HMS

4:10-4:30

Imaging in Diabetes, Recent Advances

Jason Gaglia, MD
Assistant Professor of Medicine, HMS

4:30-5:00

Alzheimer's Disease : Why imaging biomarkers are so important for its diagnosis and treatment

Steve Paul, MD
Third Rock Ventures

5:00-5:15

Questions and Panel Discussion

5:15

Adjourn

Saturday April 26

8:00-8:30 AM

BREAKFAST

8:30-9:00

KEYNOTE: Imaging Biomarkers in Precision Medicine

Sanjay Saini, MD
Professor of Radiology, HMS

9:00-9:30

Oncology: WHO, RECIST

Giles Boland, MD
Professor of Radiology, HMS

9:30-10:00

Revised Response Criteria for Malignant Lymphoma (Cheson)

Victorine Muse, MD
Assistant Professor of Radiology, HMS

10:00-10:30

Response Assessment using FDG-PET in Oncology

Michael Blake, MD
Associate Professor of Radiology, HMS

10:30-10:45

Questions and Panel Discussion

10:45-11:00

NETWORKING AND COFFEE BREAK

11:00-11:30

The Value of Blinded Centralized Reads

Donald P. Rosen, MD
ACR Image Metrix

11:30-12:00

Brain Tumor Volumetrics

John Chen, MD, PhD
Assistant Professor of Radiology HMS

12:00-12:30

MRI Imaging of Cancer

Mukesh Harisinghani, MD
Associate Professor of Radiology, HMS

12:30-1:00

Tumor Imaging Metrics Core

Gordon Harris, PhD
Professor of Radiology, HMS

1:00-2:00

LUNCH

2:00-2:25

Imaging Biomarkers for Multicenter Cancer Trials: What is ready for Prime Time?

Susanna I. Lee, MD, PhD
Assistant Professor of Radiology, HMS

2:25-2:55

KEYNOTE: Cancer Genetics and Imaging

Bruce Chabner, MD
Professor of Medicine, HMS

2:55-3:20

Increased value of Centralized Blinded Reads

Jacob Agris, MD, PhD
Bayer Imaging

3:20-3:30

BREAK

3:30-3:50

The Spot Sign: A Novel Imaging Biomarker for Intracerebral Hemorrhage

Javier Romero, MD
Instructor in Radiology, HMS

3:50-4:15

Imaging Biomarkers in Chronic Liver Disease

Sheela Agarwal
Instructor in Radiology, HMS

4:15-4:45

Reader Selection and Training for Centralized Blinded Reads

Udo Hoffmann, MD
Professor of Radiology, HMS

4:45-5:00

Questions and Panel Discussion

5:00 PM

Adjourn

*Program changes/substitutions may be made without notice.

REGISTRATION INFORMATION



Course Number #3424490

Physician: $500.00 (USD)
Reduced Fee for Technologists, Residents/Fellows in Training: $250.00 (USD)

Registration by credit card (VISA, Mastercard or American Express) can be made here. Registration by check (draft on a United States bank), please make payable to Harvard Medical School and mail with registration form to Harvard Medical School–Department of Continuing Education, PO Box 825, Boston, MA 02117-0825. Telephone or fax registration is not accepted. Registration with cash payment is not permitted. Upon receipt of your paid registration an email confirmation from the HMS-DCE office will be sent to you. Be sure to include an email address that you check frequently. Your email address is used for critical information including: registration confirmation, evaluation and certificate.

ACGME COMPETENCIES

This course is designed to meet one or more of the following Accreditation Council of Graduate Medical Education competencies:

  • Patient care
  • Medical knowledge
  • Professionalism
  • Practice-based learning and improvement
  • Systems based practice
  • Interpersonal and communication skills

INQUIRIES

By phone 617–384–8600, Monday–Friday, 10 AM to 4 PM (EST) or by email at: hms–cme@hms.harvard.edu.

ONLINE INFORMATION

To register or view activity information online, click here. To ensure proper registration, please add the source code 1EM found at the bottom of the registration form.

DISCLOSURE POLICY

Harvard Medical School (HMS) adheres to all ACCME Essential Areas, Standards, and Policies. It is HMS’s policy that those who have influenced the content of a CME activity (e.g. planners, faculty, authors, reviewers and others) disclose all relevant financial relationships with commercial entities so that HMS may identify and resolve any conflicts of interest prior to the activity. These disclosures will be provided in the activity materials along with disclosure of any commercial support received for the activity. Additionally, faculty members have been instructed to disclose any limitations of data and unlabeled or investigational uses of products during their presentations.

REFUND POLICY

A handling fee of $60 is deducted for cancellation. Refund requests must be received by postal mail, email or fax one week prior to this activity. No refunds will be made thereafter.

COURSE LOCATION

All sessions for this activity will be held at Massachusetts General Hospital, Richard B. Simches Building, 3rd floor, 185 Cambridge Street, Boston, MA. 02114.

ACCOMMODATIONS

Hotel rooms in Boston are limited. You are urged to make your reservations early. Please find below a list of hotels offering special rates for the hospital and/or cme courses.

The Wyndham Boston Beacon Hill is within walking distance to the Conference Center. To check availability and book a room you may call 617-742-0461 or 877-999-3223.

The Liberty Hotel offers a “Partners Healthcare/MGH rate” based on availability. Please contact the Reservations Department at 617-224-4019.

The Hilton Back Bay Hotel is also offering special rates for MGH starting at $239 per night + tax. Please click here to check availability.

Please do not purchase non-refundable airline ticket(s) until you have received an email from our office confirming your paid registration. For airline reservations contact the HMS Travel Desk toll free 1-877-4-HARVMD (1-877-442-7863) Monday – Friday 9 AM - 8 PM (EST). From outside the U.S., Canada and Virgin Islands, please call 617-559-3764.



Course #3424490





Offered by

HMS


Course Directors
Sheela Agarwal, MD
Instructor in Radiology
Harvard Medical School

Giles Boland, MD
Professor of Radiology
Harvard Medical School

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GUEST FACULTY

Jacob Agris, MD, PhD
Donald P. Rosen, MD
Steve Paul, MD

HARVARD MEDICAL SCHOOL FACULTY

Sheela Agarwal, MD
Michael Blake, MD
Giles Boland, MD
Cesar Castro, MD
Bruce Chabner, MD
John Chen, MD
Georges El-Fakhri, PhD
Jason Gaglia, MD
Alexander Guimaraes, MD, PhD
Mukesh Harisinghani, MD
Gordon Harris, PhD
Udo Hoffmann, MD
Susanna I. Lee, MD, PhD
Victorine Muse, MD
Matthias Nahrendorf, MD
Javier Romero, MD
Bruce Rosen, MD, PhD
David P. Ryan, MD
Sanjay Saini, MD

 

Copyright © 2014, Harvard Medical School, Department of Continuing Education
    Last update 2.20.2014